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Glycated Hemoglobin A1c(Boronate Acid Affinity Chromatography Method)
EUDAMEDClass IVD General (EU MDR)
Ref DC2204AModel 20T
Identity
- Trade Name
- Glycated Hemoglobin A1c(Boronate Acid Affinity Chromatography Method) EUDAMED
- Device Name
- Glycated Hemoglobin A1c(Boronate Acid Affinity Chromatography Method) EUDAMED
- Model / Reference
- 20T EUDAMEDDC2204A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978945080996 EUDAMED
- Basic UDI-DI
- B-06978945080996 EUDAMED
- EMDN Code
- W0102160102 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Glycated Hemoglobin A1c(Boronate Acid Affinity Chromatography Method) by Jiangxi Medicalsystem Biological Technology Co., Ltd. — Class IVD General — IVDD…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06978945080996 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000050651
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 6ab08f69-686a-444d-a710-a5fa95caf41d 61 fields · synced Jun 19, 2026